Glaucoma Screening Using Artificial Intelligence Assisted Clinical Model in Singapore's Diabetic Eye Screening Program

Официальное название

A Pragmatic Randomized Controlled Trial of a New Artificial Intelligence-Assisted Clinical Model in Opportunistic Screening for Glaucoma in the Singapore Integrated Diabetic Retinopathy Program

Обзор

Glaucoma is major cause of irreversible blindness and is characterized by optic nerve damage and visual field loss. Screening for glaucoma is challenging due to lack of a simple, accurate, cost-efficient and standardized process. Artificial intelligence, (AI) especially deep learning (DL) algorithms have potential to automate glaucoma detection, but have to be evaluated in real world settings, before public deployment. This study aims to evaluate the screening accuracy of a DL algorithm for glaucoma detection using colour fundus photographs (CFP) in a pragmatic randomised control trial (RCT). The algorithm will be tested in 1040 eligible patients with diabetes, recruited from the Diabetes \& Metabolism Centre's clinics under the Singapore Integrated Diabetic Retinopathy Program (SiDRP) and randomized to 2 arms: AI-assisted model vs current standard of care (grader assessment). The performance of both arms will be compared to performance of study ophthalmologist in diagnosing glaucoma. We hypothesize that the DL model has better screening performance in detecting glaucoma in the community, compared to the current practice method.

Подробное описание

Background: Glaucoma is the leading cause of irreversible blindness worldwide, characterized by optic nerve damage and visual field loss. Screening for glaucoma remains challenging due to lack of a simple, standardized, and cost-effective test. Artificial intelligence (AI), especially deep learning (DL), offers potential to improve and standardize glaucoma detection. However, its performance must be prospectively validated in real-world settings before public deployment.

Aim: To evaluate the accuracy and cost-effectiveness of a DL algorithm using colour fundus photographs (CFP) as a clinical decision support tool for glaucoma detection in a real-world setting.

Methods: A two-centre, single-blind, pragmatic randomized controlled trial (RCT) will be conducted among 1,040 adults with diabetes recruited from the Diabetes \& Metabolism Centre (DMC) and SingHealth Polyclinics-Bukit Merah under the Singapore Integrated Diabetic Retinopathy Programme (SiDRP). After fundus imaging, participants will be randomized 1:1 to AI-assisted grading or current manual grading by graders at the SiDRP reading center (520 subjects per arm). Diagnostic performance will be compared against the gold-standard glaucoma diagnosis, determined via comprehensive ocular examination including intraocular pressure measurement, visual field testing, optical coherence tomography, and dilated fundus assessment. Cost-effectiveness will be evaluated using a cohort-based Markov model to estimate lifetime costs and incremental cost-effectiveness ratios (ICERs) of the two glaucoma screening strategies.

Clinical Significance: Integrating AI into glaucoma screening can address resource constraints and streamline detection. This study will provide real-world evidence on the accuracy and cost-effectiveness of AI-based screening. If validated, it could be integrated into national screening programs to enhance early detection, reduce unnecessary referrals, and prevent avoidable blindness through a cost-efficient, scalable approach.

Вмешательства

• Диагностический тест Artificial Intelligence model to detect glaucoma
  A Vision Transformer model to detect glaucoma from fundus photos
• Другое No intervention
  Control group with current practice model by human graders

Первичные конечные точки

• Evaluation of model performance [Срок оценки: At study completion (after all fundus images have been graded and data collection is finalized; approximately within 12 months of study initiation)]

Вторичные конечные точки (2)

• Evaluation of time efficiency [Срок оценки: At study completion (after all fundus images have been graded and data collection is finalized; approximately within 12 months of study initiation)]
• Evaluation of Grader's Acceptance [Срок оценки: At study completion (after all fundus images have been graded and data collection is finalized; approximately within 12 months of study initiation)]

Критерии участия

Inclusion Criteria: We aim to recruit all eligible patients who attend Singapore General Hospital (SGH) Diabetes \& Metabolism Centre's (DMC) clinics and SingHealth Polyclinics (SHP)-Bukit Merah under the Singapore Integrated Diabetic Retinopathy Programme (SiDRP). Patients are eligible for the study if

• Aged 21 years old and above, with diabetes, including type 1 and type 2,
• Retinal photos of the patients can be taken with the fundus camera in the clinics, regardless of photos' quality, and
• They are willing and capable of providing a written informed consent form.

Exclusion Criteria: Patients meeting any of the exclusion criteria will be excluded from participation:

• Patients who have difficulty in having retinal photos taken or have difficulties in completing the ocular examination protocols according to investigator's decision.
• Any other contraindication(s) as indicated by the endocrinologists responsible for the patients.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Сингапур · 1 центр

• Singapore National Eye Centre — Singapore

Идентификаторы

NCT: NCT07243665 · ECOS Ref: 2024-3461 · MOH-OFLCG21jun-0003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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